Efficacy of Intraosseous Local Anesthesia for Restorative Procedures in Molar Incisor Hypomineralization-Affected Teeth in Children.
Uma B Dixit, Amil V Joshi
https://pubmed.ncbi.nlm.nih.gov/30294157Actively Recruiting
Phase Not Applicable
Age: 6Years - 12Years
All Genders
Healthy Volunteers
ID07352813
A Comparative Evaluation of Computer-Assisted Intraosseous and Infiltration Anesthesia During Restorative Treatment in Children With Molar-Incisor Hypomineralization
Led by Ankara Yildirim Beyazıt University · Updated on 2026-01-20
30
Participants Needed
1
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effectiveness of two anesthesia techniques—computer-assisted intraosseous and infiltration anesthesia—in children aged 6 to 12 years with Molar-Incisor Hypomineralization (MIH) affecting their permanent first molars. The study compares these methods during restorative dental treatments by measuring pain levels, behavioral responses, pulse rates, and salivary chromogranin A levels, aiming to find a minimally invasive and effective anesthesia approach for this sensitive condition. The study involves 30 children who receive both anesthesia methods in separate sessions spaced at least one week apart. Each session includes anesthesia administration using the SleeperOne® 5 device on either the right or left upper first permanent molar, followed by removal of carious tissue and restorative treatment. The order of anesthesia types is randomized, and the opposite side molar receives the alternative technique in a third session. Participants will have their pain assessed using the Visual Analogue Scale (VAS), behavior observed with the FLACC scale, and pulse rate monitored throughout the procedures. Saliva samples are collected before anesthesia, after anesthesia application, and post-treatment for biochemical analysis. Behavioral responses are video recorded for unbiased evaluation. The study will measure the need for additional anesthesia and overall anesthesia efficacy, with all data collected over multiple visits to inform best clinical practices.
CONDITIONS
Brief Title
Intraosseous vs Infiltration Anesthesia in Molar-Incisor Hypomineralization (MIH) Children
Who Can Participate
Age: 6Years - 12Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Individuals applying to the Department of Pedodontics, Ankara Yıldırım Beyazıt University Faculty of Dentistry
- Systemically healthy individuals
- Individuals without any known allergies
- Children between the ages of 6 and 12 years
- Scoring 3-4 according to the Frankl Behavior Rating Scale
- Children and their legal guardians who understand the informed consent and voluntarily provide verbal and written consent
- Children with contralateral and homologous maxillary first permanent molars affected by molar-incisor hypomineralization scoring 3-4 according to the MIH Treatment Need Index
- Children with no emergency treatment needs such as dental pain
- Both male and female volunteers
You will not qualify if you...
- None listed
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 sessions with at least 1 week between each session
Participants attend three treatment sessions spaced at least one week apart. In the first session, medical and dental histories are collected and teeth are examined without any invasive procedures. The second and third sessions each involve administration of a different anesthesia technique to a specified molar, followed by restorative dental treatment. During treatment, saliva samples and pulse rate measurements are collected, pain levels are assessed, behavioral responses are recorded, and anesthesia efficacy is evaluated.
3 treatment visits (in-person)
Trial Site Locations
Total: 1 location
1
Ankara Yıldırım Beyazıt University Faculty of Dentistry
Ankara, Turkey (Türkiye)
Actively Recruiting
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Research Team
G
Gülsevim Oda, Assistant professor, pHD
E
Esra Koçak
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Computer-assisted intraosseous anaesthesia for molar and incisor hypomineralisation teeth. A preliminary study.
C Cabasse, A Marie-Cousin, A Huet...
https://pubmed.ncbi.nlm.nih.gov/26058304"Comparative study of conventional anesthesia technique versus computerized system anesthesia: a randomized clinical trial".
S Berrendero, O Hriptulova, M P Salido...
https://pubmed.ncbi.nlm.nih.gov/32862249Effective anaesthesia when treating teeth affected by molar incisor hypomineralisation (MIH): a systematic review.
Miniar Rhaiem, Marwa Chatti, Yamina Elelmi...
https://pubmed.ncbi.nlm.nih.gov/40445534